Patient Name : MR.

SAMI ALAM KHAN Referral : SELF

Age / Gender : 40 years / Male Collection Time : May 10, 2021, 10:52 p.m.
Patient ID : 57807 Reporting Time : May 11, 2021, 05:15 a.m.
Source : DOMESTIC Sample ID :
36705

Test Description Value(s) Reference Range

SARS-CoV-2 (Qualitative RTPCR)

Sample Type Nasopharyngeal / Oropharyngeal Swab

E Sarbeco Gene Negative

ORF1 / RdRP + N gene Negative

Conclusion/Result Negative

Test Interpretation and Notes

Positive: Result indicated SARS-CoV-2 RNA is Detected from the patient's specimen by this assay
Negative: Result indicated SARS-CoV-2 RNA is NOT Detected from the patient's specimen by this assay.
The results relate only to the specimens tested and should be correlated with clinical findings.

Methodology
Reverse Transcriptase Polymerase Chain Reaction(RT PCR)

Cumulative threshold (Ct Value) ranges from 15 - 40 cycle. According to many international guidelines, Ct cutoff of more than 35 is not considered as infective as it is extremely difficult to

detect any live virus in a sample above the threshold of 35 Cycle. Test has been performed along with Internal Control (i.e. Rnase P). The Ct value of RnaseP should be below 38.

Further, there are no reliable studies to definitively prove a direct correlation between disease severity / infectiousness and Ct values, therefore it is not recommended to rely on numerical Ct values for

determining infectiousness of COVID-19 patients and deciding patient management protocols.

Clinical Significance:

1. Coronaviruses are a family of large RNA viruses with size ranging from 26 to 32 kb. These viruses are zoonotic and in human can cause respiratory infections.

2. As the coronavirus is an RNA virus it has a relatively high mutation rate resulting in rapid evolution.

3. In December 2019,a new deadly coronavirus known as 2019-nCoV, which has a high sequence similarity to SARS-CoV, was identified and has caused a pneumonia outbreak in Wuhan, China and

spread globally

Limitation:

1. The results of this test are highly dependent on the sampling technique employed, sample type, cold-chain maintenance and clinical condition.

2. Presence of PCR inhibitors (cannot be traced by technologist), specimen collected very early/late in infection or viral load lesser than the assay lower limit of detection as well as presence of rare

genotypes or mutations may result in false-negative report.

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 Patient Name : MR. SAMI ALAM KHAN Referral : SELF
Age / Gender : 40 years / Male Collection Time : May 10, 2021, 10:52 p.m.
Patient ID : 57807 Reporting Time : May 11, 2021, 05:15 a.m.
Source : DOMESTIC Sample ID :
36705

Test Description Value(s) Reference Range

3. False-positive report may be obtained in cases where there is possibility of background RNA contamination from pre analytical or in lab environment.

4. The ICMR laboratory Registration no. of Acu-MDx Laboratory and Research Center Pvt. Ltd. is is AMLRJR

5. There is poor standardization between commercially available PCR tests, and results from different institutions should not bedirectly compared. Results are best monitored using a single institution.

**END OF REPORT**

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